Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

32101–32125 of 40325

HighFDA (Devices)·Z-2541-2015·2015-09-09
Wright Medical CrossCHECK Locking Screw Recall for Intraoperative Malfunction Risk
Wright Medical Technology is recalling 107 CrossCHECK Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.
Product
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning.
Product
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2503-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
Product
KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) A tracheobronchial suction…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2699-2015·2015-09-09
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2637-2015·2015-09-09
Customed Urology Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2698-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2714-2015·2015-09-09
Customed Arthroscopy PK L/F 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2518-2015·2015-09-09
Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2490-2015·2015-09-09
Trilliant Surgical Recalls Out-of-Specification Fibula Plates
Trilliant Surgical Ltd. is recalling 28 units of VL Gridlock Fibula Plates because insufficient thread depth may limit locking screw functionality.
Product
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2580-2015·2015-09-09
Customed Recalls Pediatric Lap Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2721-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 36 Transonic Flow Probes due to programming errors that cause incorrect meter readings.
Product
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2642-2015·2015-09-09
Customed Surgical Gowns Recalled for Sterilization Validation Issues
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity.
Product
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2722-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling a 6 mm Transonic Flow Probe due to a software defect causing incorrect meter readings.
Product
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2487-2015·2015-09-09
Pointe Scientific Recalls G6PD Controls Due to Reduced Stability
Pointe Scientific is recalling G6PD Controls due to reduced reconstituted stability that may cause out-of-specification results.
Product
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0417-2015·2015-09-09
Diagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results
Diagnostic Hybrids Inc is recalling 171 MicroVue Bb Plus EIA kits because they produce concentration values approximately 50% higher than expected.
Product
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2539-2015·2015-09-09
Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues
Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.
Product
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2543-2015·2015-09-09
Roche Recalls cobas Liat Analyzers Due to Incorrect LED Components
Roche Molecular Systems is recalling five cobas Liat Analyzers because incorrect LED components were used in the printed circuit board assemblies.
Product
cobas Liat Analyzer, for in vitro diagnostic use.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2491-2015·2015-09-09
Philips Ingenuity TF PET/MR Systems Recalled for Potential Database Lockup
Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.
Product
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2667-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2540-2015·2015-09-09
Limacorporate Recalls SMR Shoulder Trial Heads Due to Assembly Issues
Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.
Product
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2720-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
Product
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2609-2015·2015-09-09
Customed Minor Laceration Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.
Product
MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2663-2015·2015-09-09
Customed Breast Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 24 units of Breast Packs due to inadequate validation of sterilization processes and package integrity.
Product
BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2730-2015·2015-09-09
Neuro Kinetics I-Portal NOTC System Recalled for Incorrect Investigational Labeling
Neuro Kinetics is recalling 45 I-Portal NOTC systems because the OVAR research test was sold with an incorrect investigational label.
Product
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2544-2015·2015-09-09
Ortho VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may reset user-configured parameters to defaults during installation.
Product
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics…
Category
Medical Device
Distribution
Distributed nationwide

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32101–32125 of 40325